Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00507091
First received: July 10, 2007
Last updated: April 3, 2009
Last verified: April 2009
  Purpose

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.


Condition Intervention Phase
Metastatic
Colorectal
Adenocarcinoma
Drug: ZD6474 (vandetanib)
Drug: Irinotecan
Drug: 5-Fluorouracil
Drug: Leucovorin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2005
Study Completion Date: June 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ZD6474 (vandetanib)
    once daily oral tablet
    Other Name: ZACTIMA™
    Drug: Irinotecan
    intravenous infusion
    Other Name: Camptosar®
    Drug: 5-Fluorouracil
    intravenous infusion
    Other Name: 5-FU
    Drug: Leucovorin
    intravenous infusion
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed metastatic colorectal adenocarcinoma
  2. Not amenable to surgery or radiation therapy
  3. For first or second line chemotherapy

Exclusion Criteria:

  1. Brain metastases or spinal compression
  2. Last prior chemotherapy discontinued within 4 weeks before start
  3. Last dose radiotherapy within 4 weeks of start
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507091

Locations
Belgium
Research Site
Gent, Belgium
United Kingdom
Research Site
Belfast, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Mark Saunders, MD AstraZeneca
Study Director: Peter Langmuir AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00507091     History of Changes
Other Study ID Numbers: D4200C00038
Study First Received: July 10, 2007
Last Updated: April 3, 2009
Health Authority: United Kingdom: National Health Service
Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by AstraZeneca:
ZD6474
Irinotecan
5-Fluorouracil
Leucovorin
colorectal

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Fluorouracil
Irinotecan
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014